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Sr. Regulatory Affairs Specialist

United Kingdom, Warrington 80.00 GBP / Hour · Job Posted April 16, 2026

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Job Description

Are you a proactive regulatory professional looking to lead critical compliance activities in the life sciences sector? We are seeking a Sr. Regulatory Affairs Specialist to join a dynamic international team for a 12-month contract. This role offers the flexibility of remote or hybrid working and is based out of Warrington.

Job Responsibility

  • Lead and manage notification activities for IVDR CDx performance studies involving leftover samples
  • Prepare, review, and submit notification packages to EU Competent Authorities and Ethics Committees
  • Partner with Clinical, Medical, Legal, Quality, and Project Management teams to ensure submissions are both compliant and timely
  • Act as the primary point of contact for EU regulatory authorities, responding to inquiries and requests for additional information
  • Provide regulatory expertise to project teams regarding study design and documentation requirements

Requirements

  • Bachelor's degree in Life Sciences, Biomedical Sciences, or a related field
  • At least 3+ years in Regulatory Affairs or Clinical Regulatory functions within the IVD, medical device, or pharmaceutical industry
  • Solid working knowledge of IVDR (EU2017/746), particularly regarding performance studies
  • Proven experience with EU regulatory submissions and interactions with Competent Authorities
  • Strong project management abilities
  • Excellent English communication skills
  • Ability to work autonomously in a matrixed environment

What we offer

Laptop and accessories will be provided

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